Vesalio, Inc.: FDA clearances and approvals
Vesalio, Inc. has 6 FDA 510(k) clearances (first 2021, latest 2026), across 6 product codes in 2 review panels. Median 510(k) review time: 221 days. Since 2017 its median was 221 days, against 108 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 3 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 267 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 3 | 179 |
| 2026 | 2 | 245 |
Review time against the same product codes
Since 2017, Vesalio, Inc.'s cleared 510(k)s took a median 221 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NRY | Catheter, Thrombus Retriever | 1 | 1 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 1 | 1 |
| QEX | Coronary Mechanical Thrombectomy With Aspiration | 1 | 1 |
| QEZ | Aspiration Thrombectomy Catheter | 1 | 1 |
| QJP | Catheter, Percutaneous, Neurovasculature | 1 | 1 |
Plus 1 more product codes.
Review panels
- Cardiovascular (3)
- Neurology (2)
Most recent Vesalio, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254211 | pVasc Net Mechanical Thrombectomy Device | — | 2026-08-05 | 219 |
| K251097 | V-DAC Catheter | QJP | 2026-01-06 | 271 |
| K253407 | NeVa PV Thrombectomy Device | QEX | 2025-11-24 | 55 |
| K251006 | NeVasc Aspiration System | NRY | 2025-11-10 | 223 |
| K251312 | Vesalio Peripheral System | QEZ | 2025-10-24 | 179 |
| K201085 | NeVa PV Thrombectomy Device | QEW | 2021-01-15 | 267 |
Recalls
openFDA lists no recalls under a recalling firm named Vesalio, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Vesalio, Inc. is the industry lead sponsor of 3 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT04969471: NATURE (EnVast as an Adjunct PPCI in Subjects Presenting With STEMI) (Active not recruiting, started 2021-12-09)
- NCT04562194: NeVa ONE Registry Study (Recruiting, started 2020-07-01)
- NCT03611790: Vesalio NeVa VS for Symptomatic Cerebral Vasospasm Following aSAH (The VITAL Study) (Completed, started 2018-12-19)
Frequently asked questions
How many FDA 510(k) clearances does Vesalio, Inc. have?
Vesalio, Inc. has 6 FDA 510(k) clearances (first 2021, latest 2026), across 6 product codes in 2 review panels.
How long does FDA take to clear Vesalio, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Vesalio, Inc.'s cleared 510(k)s is 221 days. Since 2017: 221 days, versus 108 days for all cleared 510(k)s in the same product codes.
What devices does Vesalio, Inc. make?
Its most frequent FDA product codes are NRY (Catheter, Thrombus Retriever, 1); QEW (Peripheral Mechanical Thrombectomy With Aspiration, 1); QEX (Coronary Mechanical Thrombectomy With Aspiration, 1).
Has Vesalio, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Vesalio, Inc. Related entities may recall under other names.
Next steps
- See all 6 Vesalio, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NRY, Vesalio, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.